A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)

Summary: This is a first-in-human study of BMS-986506 in participants with advanced Clear Cell Renal Cell Carcinoma (ccRCC). The primary objective of this study is to find out if BMS-986506 is safe and can be tolerated when taken alone or in combination by participants with ccRCC.
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Short title: A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
clinicaltrials.gov

Official title: A Phase 1/1b Open-label, Multi-center Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
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Sources for study design

Number of Participants With Adverse Events (AEs)
Timeframe: Up to approximately 2 years from first dose of BMS-986506
Number of Participants With Serious Adverse Events (SAEs)
Timeframe: Up to approximately 2 years from first dose of BMS-986506
Number of Participants With AEs Meeting Protocol Defined Dose-limiting Toxicity (DLT) Criteria
Timeframe: Up to approximately Day 28
Number of Participants With AEs Leading to Discontinuation
Timeframe: Up to approximately 2 years from first dose of BMS-986506
Number of Participants With AEs Leading to Deaths as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 5.0
Timeframe: Up to approximately 2 years from first dose of BMS-986506

Maximum Observed Plasma Concentration (Cmax) of BMS-986506
Timeframe: Up to approximately Day 85
Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986506
Timeframe: Up to approximately Day 112
Area Under the Concentration-time Curve Within a Dosing Interval (AUC-TAU) of BMS-986506
Timeframe: Up to approximately Day 112
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Timeframe: Up to approximately 3 years from first dose of BMS-986506
Disease Control Rate (DCR) as Assessed by RECIST v1.1
Timeframe: Up to approximately 3 years from first dose of BMS-986506
Duration of Response (DOR) as Assessed by RECIST v1.1
Timeframe: Up to approximately 3 years from first dose of BMS-986506
Time to Response (TTR) as Assessed by RECIST v1.1
Timeframe: Up to approximately 3 years from first dose of BMS-986506

Sources for outcomes

Participants must have histologically confirmed diagnosis of locally advanced or metastatic ccRCC.
For part 1: Participants must have already had at least two different treatment plans in the past, including immunotherapy and a targeted therapy.
For part 2: Participants must have had at least one standard treatment plan that included both a PD-1/L1 inhibitor and a VEGF-TKI (either together or one after the other).
Part 3: Participants must have had at least 1 standard treatment regimen (including a PD-1/L1 checkpoint inhibitor and/or a VEGF-TKI).
Part 4: Participants must not have received prior systemic therapy for metastatic RCC, but may have received prior adjuvant therapy for completely resected RCC with PD-1 inhibitor if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy.
Eastern Cooperative Oncology Group performance status of 0 to 1.

Inability to administer and/or tolerate oral medication without chewing, breaking, crushing, or otherwise altering the product dosage form.
Part 2A: Participants who have received more than 3 prior systemic regimens for locally advanced or metastatic ccRCC including prior treatment with HIF2a inhibitors.
Part 2A and Part 4: Participants who have received prior treatment with belzutifan (or another HIF2a inhibitor).
Part 3B and Part 4B: Participants who have received prior ipilimumab (or another anti-CTLA-4 containing antibody).
Participants who have hypoxia as defined by a pulse oximeter reading < 92% at rest or requires intermittent or chronic supplemental oxygen.
Participants who have received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) within 28 days prior to the first dose of study intervention.
Part 3 and Part 4: Participants with a history of Grade ≥3 immune-mediated AEs leading to discontinuation of prior immunotherapy.
Other protocol-defined Inclusion/Exclusion criteria apply.

Sources for eligibility